Endoscopic mesh delivery system with integral mesh stabilizer and vaginal probe

ABSTRACT

A mesh delivery system for sacral colpopexy and other procedures involving surgical mesh is disclosed. The system uses a mesh stabilizer ( 30 ) that is introduced in a compressed configuration through a surgical port into the abdomen, and a vaginal probe ( 10 ) (inserted through the vagina) with a magnetic or non-magnetic head that engages with the mesh stabilizer ( 30 ), anchoring it in position. The mesh stabilizer ( 30 ) employs a pseudoelastic shape memory alloy, and folds compact to deliver multiple mesh straps or a single Y-shaped surgical mesh in a streamlined configuration into the abdomen for facilitating the sacral colpopexy procedure. After delivery, the stabilizer ( 30 ) expands to a functional configuration where it interfaces with the probe ( 10 ) head and stabilizes and adjustably feeds the mesh strap(s) in preparation for fixation to the vaginal muscularis while maintaining stabilization of the mesh on the vaginal muscularis and while keeping excess mesh from obscuring the surgeons view. After fixation of the mesh to the vaginal muscularis, the stabilizer can be removed back through the surgical port.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application derives priority from U.S. Provisional PatentApplication 61/638,256 filed 25 Apr. 2012, and is a continuation-in-partof U.S. application Ser. No. 12/973,189 filed 20 Dec. 2010.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to medical methods and devices forperforming sacral colpopexy.

2. Background Art

The sacral colpopexy operation is designed to recreate support to theupper vagina by attaching straps of permanent synthetic mesh to theupper anterior and posterior vaginal walls and then suspending the otherend of the straps on the anterior surface of the sacrum. This operationis one of many operations described for the correction of pelvic organprolapse but is considered the gold standard for correction of prolapseof the upper vagina. See, for example, “Long-Term Success of AbdominalSacral Colpopexy Using Synthetic Mesh”, Culligan et al. Am J ObstetGynecol (December 2002). This operation can be done either forcorrection of vaginal vault prolapse in patients who have previouslyundergone hysterectomy or can be done at the time of hysterectomy inpatients with uterine prolapse. In the latter case, many physiciansprefer to perform supracervical hysterectomy because of data suggestingthat mesh related complications are less likely in cases ofsupracervical compared with total hysterectomy.

The sacral colpopexy operation was first described as being done througha large incision in the abdominal wall (laparotomy) and is stillpredominantly done in that manner.

FIG. 1 is a diagrammatic illustration of the surgery, which is usuallyperformed under general anesthesia. An incision is made in the lowerabdomen. The bladder and rectum are freed from the vagina and permanentmesh is secured to the sacrum (upper tailbone) to support the front andback wall of the vagina. The mesh is sutured to the vagina. Theperitoneum (lining of the abdominal cavity) is closed over the mesh.There is growing interest in performing this operation via less invasiveapproaches, such as laparoscopy or robot-assisted laparoscopic surgery,but existing vaginal probes, surgical instruments and meshconfigurations are not well-suited for this.

There are a variety of vaginal probes designed for use in treatingdisorders of the female pelvic floor such as pelvic organ prolapse,urinary incontinence, and sexual dysfunction.

For example, U.S. Pat. No. 6,741,895 to Gafni et al. (Medoc Ltd.) issuedMay 25, 2004 shows a vaginal probe and method for stimulation of thenerves of the vagina with the purpose of testing their reaction tostimuli in the hope of defining, and treating sexual dysfunction inwomen. A balloon structure is used to provide tactile stimuli. When theballoon is inflated, these projections poke into the vagina.

United States Patent Application 20060199994 by Inman et al. (AMSResearch) issued Sep. 7, 2006 shows surgical instruments useful inpelvic floor repair procedures. The claims require a handle attached toa slender, metal, curved rod.

United States Patent Application 20030220538 to Jacquetin issued 27 Nov.2003 discloses a particular mesh implant for treating anterior vaginalprolapse.

U.S. Pat. No. 6,932,759 to Kammerer et al. issued Aug. 23, 2005 shows asurgical instrument and method for treating female urinary incontinencewith a curved needle-like element and a proximal tape, or mesh, forimplanting into the lower abdomen of a female to provide support to theurethra. A second curved needle element is used for simultaneousattachment to the distal end of the first needle.

The IVS Tunneller™ device is available from U.S. Surgical of Norwalk,Conn. The IVS device comprises a fixed delta wing handle, a hollow metaltube and a stylet that is placeable within the tube. The stylet has arounded plastic tip on one end and an eyelet at the other end. Thedevice may be used to implant a polypropylene tape for infracoccygealsacropexy and other surgical procedures.

Although the foregoing references have some relevance, they are notsuitable for sacral colpopexy, and would not be useful in this lattercontext. U.S. Pat. No. 6,328,729 (General Surgical Innovations) toJervis issued Dec. 11, 2001 shows a colporrhaphy method and apparatus inwhich a tunneling member is advanced and a balloon inflated, therebydissecting the anatomical space. Again, this device is designed tofacilitate dissection of anatomical spaces and is not useful for sacralcolpopexy.

Sacral colpopexy has been performed laparoscopically through multipleports, in one case three to four ports for a daVinci® robot, and one ortwo ports for the assistant. The polypropylene mesh was attachedrobotically to the sacral promontory and to the vaginal apex usingGortex™ sutures. Whether performed manually or robotically, there arestill inherent problems with manipulating the end effectors andstabilizing the vagina.

Synthetic mesh is commonly used in treatment of pelvic organ prolapse tocreate a “hammock” to lift the prolapsed organ and return it to itsnormal position. Similar synthetic or biological meshes are also used inhernia repair to cover the hernia defect, as well as in repair ofabdominal wall defects, and abdominal reconstruction. In prolapse repairpolypropylene knitted mesh fabrics are most common, and these are wovenfrom monofilament yarns. There are a variety of prolapse repair mesheson the market such as, Popmesh™ by Caldera, Timesh™ by PFM, Avaulta byBard, Polyform™ by Boston Scientific, Gynecare Gynemesh by Ethicon, andIntePro® Lite. The IntePro® Lite, one of the most commonly used meshes,is made of knitted monofilament polypropylene. It is manufactured byAmerican Medical Systems. In hernia repairs many different synthetic orbiologic materials have been proposed over time with varying pore sizesand monofilament fiber compositions, but no single material has gaineduniversal acceptance. In the prolapse context, the available meshconfigurations are typically elongate strips, or pre-formed U-shaped orY-shaped patches with two arms for placement on the sacrospinousligaments (in the latter case the main stem is placed over therectovaginal fascia and perineal body).

For example, United States Patent Application 20060015001 to Staskin etal. (American Medical) issued Jan. 19, 2006 shows a sling deliverysystem to treat urological disorders. The U-shaped configuration of thesling assembly also allows the sling to be adjusted during and/or afterimplantation. This device is designed for treatment of incontinence andneither it nor any of the foregoing devices are suitable for performanceof sacral colpopexy.

United States Patent Application 20030195386 to Thierfelder et al. (AMSResearch Corporation) issued Oct. 16, 2003 shows a surgical kit usefulfor performing a surgical procedure such as a sacral colpopexy with animplantable Y-shaped suspension for treating pelvic floor disorders suchas vaginal vault prolapse. AMS also has a device called the Straight-In™System which uses a long slender instrument designed for endoscopic usethat screws a small coil of wire through the pre-formed Y-graft mesh andinto the sacrum, thereby obviating the need to suture the mesh to theanterior longitudinal ligament of the sacrum.

FIG. 2 is a front view of an exemplary single-strip mesh 3 and Y-strip4.

In all configurations the mesh is either sutured or stapled in place.Regardless of mesh composition, pore size or configuration, it is alwayscrucial to lay the mesh over the site without tension and to make surethat it does not fold or bunch up in the process. The mesh being suturedtoo tight or bunching are common causes of complications. This requiresa combination of a reliable mesh dispensing system and stabilizer forstabilizing the mesh in the desired position during suturing orotherwise permanently affixing (e.g.—surgical adhesive) of the mesh tothe vagina.

Performing the operation laparoscopically using currently availableequipment has several inefficiencies. One of the problematic areas inperforming laparoscopic or robotic sacral colpopexy is introduction andpositioning of the mesh straps during permanent fixation of the mesh tothe vagina. Introduction and dispensing of the mesh straps into the bodycavity is difficult using laparoscopic instruments and bunching easilyoccurs. Guiding them into proper orientation is equally awkward.Maintaining them in the proper position during suturing or otherwisepermanently affixing (e.g.—surgical adhesive) requires constantvigilance on the part of the assistant as they frequently requirerepositioning. Additionally, maintaining the mesh straps in positionoccupies one or more instruments that could be utilized elsewhere (forinstance in retracting the surrounding tissues for bettervisualization). Sometimes portions of the mesh will drape over andobscure the site of interest, particularly during fixation of theposterior strap of mesh to the posterior vaginal wall.

It has been proposed in other contexts to stabilize one surgicalinstrument using a second instrument inserted through another incision.For example, U.S. Pat. No. 7,052,453 to Presthus et al. (SolorantMedical) issued May 30, 2006 shows an incontinence treatment withurethral guide that docks with a probe. Generally, the guide can beinserted into a first body orifice and the probe can be inserted into asecond body orifice and placed in a predetermined position relative tothe guide so as to position the treatment surface adjacent the targettissue in the second body orifice. The urethral guide and probe mayalign RF sensors relative to a tissue surface.

It would be greatly advantageous to provide a mesh delivery system thatovercomes the alignment and positioning problems using a docking conceptas above, rendering the mesh attachment for sacral colpopexy lesscomplex and potentially, less time consuming. If the operation can berendered less time consuming, and with a lower learning curve, there ispotential for the operation to be transformed in to one that is doneprimarily laparoscopically (less invasively), similar to what hasalready occurred with cholecystectomy (removal of the gall bladder) andtherefore reduce patient morbidity and hospitalized care.

It would also be advantageous to provide a mesh delivery system forsacral colpopexy and other procedures requiring fixation of a composite,polyester or polypropylene mesh (performed via laparotomy orlaparoscopically) including a method of dispensing said mesh from astabilizer or other device that improves dispensing efficiency, accuracyand reduces clutter, and an apparatus capable of dispensing said mesh inaccordance with the method.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a mesh deliverysystem for sacral colpopexy that facilitates attachment of supporting(anterior and posterior) mesh straps.

It is another object to provide a mesh delivery system for sacralcolpopexy (performed via laparotomy or laparoscopically) that uses aconventional laparoscopic surgical tool (e.g.—laparoscopic grasper) forintroducing the mesh in combination with a mesh stabilizer into dockedattachment to a vaginal probe which is placed in the vagina exteriorly,to thereby stabilize the inserted mesh for permanent fixation to thevaginal tissue.

It is another object to provide a mesh stabilizer with onboard supply ofsurgical mesh capable of minimally invasive laparoscopic orrobot-assisted laparoscopic introduction into the abdominal cavity.

It is another object to provide a pseudo-elastic mesh stabilizer formedwith shape memory alloy and carrying an onboard supply of surgical meshfor compressed-keyhole introduction into the abdominal cavity, anddetachment and expansion to a functional state in which it facilitatesdispensation of the mesh as well as suturing or otherwise permanentlyaffixing (e.g.—stapling or surgical adhesive) of the mesh to theanterior and posterior vaginal walls.

It is still another object to provide a pseudo-elastic mesh stabilizerthat when surgically inserted into the abdominal body cavity conforms toa vaginal probe inserted into the vagina, docks magnetically to theprobe atop the vaginal apex thereby sandwiching the vaginal apex betweenitself and the probe, and which independently carries the onboard supplyof surgical mesh anchoring the mesh in position on the vaginal apex evenafter release and removal of the inserter, to facilitate repositioning,dispensation and suturing of the mesh to the anterior and posteriorvaginal walls.

It is another object to stabilize the vagina in a fixed but adjustableposition during dissection of the tissue planes necessary to allow safeattachment of mesh to the vagina without causing injury to the rectum orbladder.

It is another object to stabilize the vagina in a fixed but adjustableposition during fixation of mesh to the vagina.

It is another object to stabilize the loose end(s) of the surgical mesh(the end(s) not being sutured to the vaginal tissue) to prevent theloose ends from obscuring the surgeons vision during the procedure.

It is another object to allow the surgical mesh to be adjustablypositioned with respect to the mesh stabilizer and the vaginal tissuefollowing placement of the mesh stabilizer on the vaginal apex whilemaintaining stabilization of the mesh by the mesh stabilizer.

Other objects, features, and advantages of the present invention willbecome more apparent from the following detailed description of thepreferred embodiments and certain modifications thereof in which a meshdelivery system is provided for sacral colpopexy. The system generallycomprises an elastic mesh stabilizer having a plurality of deployablearms and a magnetic docking member(s), a packaging cylinder forintroduction of the mesh stabilizer through a conventional port into theabodomen using a conventional grasper or introducer, and a vaginal probewith a magnetic probe tip that interfaces with the magnetic dockingmember(s) of the mesh stabilizer. The probe may be handheld,robotically-held, or adjustably anchored via a supporting framework to asupport surface such as the operating table. The vaginally placed probeessentially acts as a stabilizer for the vaginal tissue duringdissection of the bladder and rectum away from the vagina and thenduring suturing or otherwise permanently affixing (e.g.—stapling orsurgical adhesive) of mesh to the vagina. When the probe is insertedinto the vagina to the vaginal apex, the magnetic portion of the meshstabilizer is attracted to the magnetic tip of the vaginal probe therebyanchoring the mesh stabilizer to the tissue of the vaginal apex insidethe abdominal body cavity. The mesh stabilizer is designed to deliveranterior and posterior mesh strap(s) for sacral colpopexy through astandard laparoscopic port, and then stabilize the mesh straps on thevaginal apex during fixation. It is equally beneficial to use the meshstabilizer via a laparotomy approach. In general use the mesh stabilizerwith onboard supply of mesh is, maintained in a compressed configurationwhile introduced by a standard introducer/grasper through a laparoscopicport into the abdomen. The mesh stabilizer expands to a functionalconfiguration conforming to the interior of the vaginal apex, andmagnetically docks to to the probe therebeneath. The expansion of themesh stabilizer deploys and unfurls the onboard mesh from a compressedconfiguration (unwrinkes the mesh) and positions/anchors the meshinteriorly over the vaginal apex. The docking engagement of the meshstabilizer to probe through the vaginal tissue locks the mesh stabilizerwith mesh straps in place in the desired site with the muscular walls ofthe vagina sandwiched between the vaginal probe and the mesh stabilizer.The endoscopic introducer/grasper is removed, and theindependently-anchored mesh stabilizer facilitates suturing or otherwisepermanently affixing (e.g.—stapling or surgical adhesive) of the mesh tothe anterior and posterior vaginal walls. After permanent fixation ofthe mesh, the introducer is reinserted into the abdomen and used toretrieve the mesh stabilizer component. The system greatly facilitatessuturing or otherwise permanently affixing (e.g.—stapling or surgicaladhesive) of the surgical mesh to the vaginal walls and results in asafer, more effective, less invasive procedure.

BRIEF DESCRIPTION OF DRAWINGS

Other objects, features, and advantages of the present invention willbecome more apparent from the following detailed description of thepreferred embodiments and certain modifications thereof when takentogether with the accompanying drawings in which:

FIG. 1 is a diagrammatic illustration of a completed sacral colpopexysurgery in which straps of mesh attached to the upper vagina inferiorlyare suspended on the anterior longitudinal ligament of the sacrumsuperiorly.

FIG. 2 is a front view of an exemplary single-strip mesh 3 and Y-strip4.

FIG. 3 is a side perspective view of a mesh delivery system (with mesh 3on the stabilizer 30) according to the invention.

FIG. 4 is a front view of the mesh stabilizer 30 while in a flattened(pre-shaped) configuration (without the mesh 3).

FIG. 5 is a top perspective view of the mesh stabilizer assembly 30(including mesh 3) with embedded magnetic members (130, 131) encased ina plastic shell 128.

FIG. 6 is a side perspective view of the mesh stabilizer assembly 30 ina compact folded configuration being loaded into the packaging cylinder137.

FIG. 7 is a side perspective view of the mesh stabilizer assembly 30inside cartridge 137 being loaded into a surgical port 60.

FIG. 8 illustrates a packing funnel 70 which may be provided to simplifyjust-in-time packing of the mesh stabilizer 30, into the cartridge 137.

FIG. 9 shows the use of a loading tether 80.

FIG. 10 shows the use of a protective skirt 85

FIG. 11 is a top perspective view of the vaginal probe 10.

FIG. 12 is a side perspective view of the vaginal probe 10.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As described above, the present invention is a method and apparatus forintroducing, positioning and anchoring a surgical mesh or implementfreestanding at a surgical site on an anatomical tissue structureinteriorly of the human body. The method and device can be used for allforms of surgical repair of the female condition vaginal prolapse, andis especially well suited for the minimally invasive laparoscopicapproach where the surgical mesh is introduced into the female cavitythrough surgical ports (such a trocars). The present method and device,accurately positions, and reliably stabilizes the surgical meshfreestanding against vaginal tissue structure during the surgicalprocedure without handheld exterior support from surgical inserters orgraspers. The invention may be used for a variety of different proceduretypes, such as for delivering surgical mesh, staples or other surgicaltools or implements to a site during hernia, cholecystectomy (removal ofthe gall bladder) or other procedures. A preferred embodiment of theinvention will herein be described in the context of a mesh deliverysystem for sacral colpopexy. The system employs a vaginal probe that isinserted vaginally, and a mesh stabilizer that is insertedlaparoscopically through the abdominal wall into the lower abdominalcavity which then expands after insertion, and which magnetically docksthrough the vaginal tissue to the vaginal probe (interior in thevagina). The mesh stabilizer carries a payload of mesh, and can be leftfreestanding while docked for secure dispensing of mesh during theprocedure, thereby overcoming alignment and positioning problems whenplacing and securing the surgical mesh on the vaginal tissue.

The probe tip of the vaginal probe has at least one and preferably anarray of embedded magnetic member(s). The probe is inserted into thevagina and is positioned with the probe tip on one side of the vaginalapex, or other anatomical tissue structure for other procedures. A meshstabilizer with its mesh payload is loaded (while in a compressed state)into a cartridge, the cartridge is loaded into a trocar or other port,and the surgical mesh assembly is then dispensed from the cartridgethrough the port into the abdomen using a conventional laparoscopicgrasper/inserter or similar surgical tool. Once the mesh assembly passesthrough the port (inside the abdomen) the mesh assembly expands from itscompressed state to an expanded state, and it is maneuvered inside theabdominal cavity by a grasper, needle driver or other instrument, intoposition at a desired surgical site against the tissue of the vaginalapex.

The mesh stabilizer likewise has at least one magnetic member attachedand, once in position, the magnetic member is attracted to a magneticmember on the probe head which is positioned directly behind and insidethe vaginal apex. This magnetically docks and stabilizes the meshstabilizer at the surgical site on the anatomical tissue structure,e.g., vaginal apex. The payload of mesh attached to the mesh stabilizercan then be dispensed and adjusted on the vaginal tissue, the stabilizerkeeping it tensioned and flat against the tissue of the vaginal apexduring permanent suturing. When fixation is completed the meshstabilizer is grasped and removed. This process of placing, holding andsecuring the surgical mesh to the vaginal apex is less time consuming,less prone to error than conventional surgical processes, and mayfacilitate transition to single-incision laparoscopic or roboticapproaches to sacrocolpopexy which is less invasive thereby reducingmorbidity for the patient as well as reducing overall hospitalized care.

FIG. 3 illustrates the mesh stabilizer 30 containing two separate stripsof mesh 3 (as per item 3 of FIG. 2), immediately before it docks andconforms to probe 10, thereby clamping the tissue of the vaginal apex(not shown) between mesh 3 and probe 10. The probe 10 may be anyconventional vaginal probe modified as described below, and may behandheld, robotically-held, or adjustably held via a supportingframework to a support surface such as the operating table. Inaccordance with the stabilization aspect of the present invention, theprobe 10 is equipped with at least one and preferably an array ofmagnetic members, for example, permanent magnets embedded in its tip.When a single magnetic member is used it may be recessed in the frontcenter of the probe 10 head. However, the illustrated probe 10embodiment includes a plurality (such as four) permanent magnetic disks110-113 arranged in pairs on opposing sides of the probe 10 head as thisindexes the mesh stabilizer 30 against inadvertent rotation.Specifically, a first pair of permanent magnetic disks 110, 111 isencased in a first plastic inset 108, and a second pair of permanentmagnetic disks 112, 113 is encased in a second plastic inset 109. Theinsets 108, 109 are inlaid flush into recesses in the probe 10 head onopposing sides thereof as shown, and are bonded or otherwise adheredthereto. In use, the vaginally placed probe 10 is inserted into thevagina and essentially acts as a stabilizer for the vaginal tissueduring dissection of the bladder and rectum away from the vagina andthen during fixation of mesh to the vagina.

The mesh stabilizer 30 is a bent wire frame structure likewise having atleast one and more preferably an array of corresponding magneticmembers, for example, permanent magnets embedded in its tip. One skilledin the art should understand that if the magnetic member(s) on probe 10are permanent magnets, the magnetic member(s) on mesh stabilizer 30 needmay either be formed of attracted ferromagnetic material such as steel,or may be permanent magnets of opposing polarity, and vice versa. In theillustrated embodiment, opposing polarity permanent magnets are used onboth. Thus, mesh stabilizer 30 has at least one permanent magnetic disksecured thereto, and preferably a plurality (four) permanent magneticdisks 130-133 in cooperative alignment with those of probe 10. As withthe probe 10, in the illustrated embodiment, a first pair of permanentmagnetic disks 130, 131 is encased in a first plastic shell 128 attacheddistally to a first side of the mesh stabilizer 30, and a second pair ofpermanent magnetic disks 132, 133 is encased in a second plastic shell129 attached distally to the other side. The magnetic disks 130-133 maybe molded inside shells 128, 129.

The magnetic disks of probe 10 and those of mesh stabilizer 30 align inpairs 113:130; 112:131; 110:132; 111:133, which allows for indexedrelative linear and rotational positioning of the mesh stabilizer 30against the vaginal apex. With the probe 10 (inserted vaginally)underlying the vaginal apex, the magnet(s) 130-133 of the meshstabilizer 30 (inserted abdominally) are attracted to the magnets110-113 of the probe 10 tip thereby anchoring the mesh stabilizer 30 tothe vaginal apex inside the abdominal body cavity.

The mesh stabilizer 30 includes a wireframe body which may be formed bylaser-cutting pseudoelastic material sheet stock into a flat wire framestructure (shown in FIG. 4 and described below), and then bending theflat structure into a three-dimensional shape (as depicted and describedwith regard to FIG. 3) conforming to the probe 10 head.

FIG. 4 is a front view of an exemplary mesh stabilizer 30 cut patternprior to bending or attachment of permanent magnetic disks 130-133. Meshstabilizer 30 may be laser cut from any resilient or pseudoeleasticsheet material in which deformation can be fully recovered uponunloading to the zero-stress state. Many metals exhibit pseudoelasticeffects, but in the present context Ni—Ti based alloys (as well as othershape memory alloys) are preferred because of their material properties(super elastic) as well as their chemical and biological compatiblilitywith the human body. See, Castleman et al., “The Biocompatibility ofNitinol,” in Biocompatibility of Clinical Implant Materials, vol. 1,Williams DF (ed), CRC Press, p 129 (1981). The pseudoelastic alloy ofthe present invention preferably contains 55-56 percent Nickel and 44-45percent Titanium, plus a remainder of one or more additional ternaryalloying elements. A simple binary Ni—Ti of 56% Nickel and 44% Titaniumis well suited and readily available from a variety of vendors includingNorman Noble, a leading medical supplier. The mesh stabilizer 30 furthercomprises a first side 32 and a second side 33 joined together at ajuncture 34, said first side and second side 32, 33 comprisingdiametrically-extending mesh stabilizing wire frameworks. The juncture34 is for the attachment of a rearwardly-protruding ball-and-stem 47 forgripping, manipulating and releasing the mesh stabilizer 30, and forsecuring the ends of mesh 3, 4. The juncture 34 may also provide forattachment of a forwardly-facing magnetic member (not used in thecurrent emvodiment), if so desired. In the preferred embodiment the meshstabilizing wire frameworks on the first side and second side 32, 33 aremirror opposites. Each mesh stabilizing framework further comprises anelongate main stem 45, a pair of outwardly-protruding spring arms 35, 37branching outward from along the main stems 45, and a distal pair ofdetent-prong fingers 38, 39 at the end of each stem 45 for slide-lockinsertion into the plastic shells 12, 129 (see FIG. 3). The main stems45 may optionally each be formed with a grasping feature 40, such as aloop (pictured), elbow or like feature for ease of grasping/manipulationin the jaws of a grasping instrument. The grasping feature 40 alsoallows the mesh stabilizer 30 to be gripped and manually open or closed.The protruding spring arms 35, 37 flare outward and angle parallel withmain stems 45, and are preferably formed with distal tabs 40 forcatching the weaves of the mesh 3, 4 to spread/tension it across thevaginal apex.

After initial laser-cutting as described above, the wireframe of meshstabilizer 30 is permanently formed by bending into a three-dimensionalshape with the first side 32 and second side 33 bent or arched at anangle in a V- or U-shape at juncture 34 in order to generally conform tothe bulbous arc of the probe 10 head. This way, as seen in FIG. 3, themesh stabilizer 30 attaches to the probe 10 head with the first side 32overtop and second side 33 underneath. The four disc permanent magnets130-133 couple to those of the probe 10 head as shown in FIG. 3, and theball-and-stem 47 protrudes directly outward and rearward from thejunction 34 to provide a means for grasping and ease ofinsertion/removal, and as well for temporarily securing the ends of mesh3, 4.

Each mesh stabilizer 30 is adapted for carrying a payload of two stripsof mesh 3, one for the upper vaginal apex and one for the lower.Alternatively, the mesh stabilizer 30 will accommodate a Y-shaped singlepiece of surgical mesh 4 (FIG. 2). The opposing main stems 45 bothsecure and dispense the onboard payload of mesh 3, 4 in accordance withan improved method of loading the payload and dispensing that is moreefficient, accurate, and which reduces clutter and bunching.

Specifically, payload loading comprises the following steps. Ifindividual strips of mesh 3 are loaded into the mesh stabilizer 30 asseen in FIG. 5, one end of each strip 3 is placed at the junction 34between the opposing main stems 45 and the other ends of the strips ofmesh 3 are run outward around the shells 128, 129 (and encased magneticmembers 130-133), and are folded back around the shells 128, 129 (asshown by dotted lines in FIG. 3) and temporarily pinned onto theprotruding ball-and-stem 47. The diverging spring arms 35, 37 are highlyresilient and penetrate the weaves of the mesh at two spaced points, thepads 42 retaining it in the loaded position. The spring arms 35, 37 arebiased outward by the mesh 3, leaving a residual inward bias when themesh 3 is fully loaded. This residual inward bias tends to clamp themesh 3 under the spring arms 35, 37 (which are threaded through pores ofthe mesh 3) and prevents the mesh from falling off the arms 35, 37. Thebias is sufficient to keep the mesh intact, flattening it against thevaginal apex, and yet it allows adjustment of the position of the mesh 3relative to the mesh stabilizer 30 and vaginal apex while maintainingstabilization of the mesh 3 on the mesh stabilizer 30.

After docking of the loaded mesh stabilizer 30 to probe 10, the magnets130-133 of mesh stabilizer 30 grip the corresponding magnets 110-113embedded in the probe head and secure the mesh stabilizer 30 in place.The opposing resilient main stems 45 and spring arms 35, 37 of meshstabilizer 30 conform to the vaginal tissue over the face of the probe10 head both overtop and underneath, and at this point theinserter/grasper can be released from the ball-and-stem 47 andwithdrawn. To then dispense the mesh payload, the ends of the strips ofmesh 3 are unpinned and fed outward past the spring arms 35, 37 underthe shells 128, 129 and encased magnetic members 130-133, the springarms 35, 37 both spreading and flattening the mesh 3 as it isfrictionally withdrawn under the magnetic members 130-133 and shells129, 129. The outwardly-splayed spring arms 35, 37 release the weaves ofthe mesh 3 during extraction, but catch the mesh 3 if it tries to backup. The spring pressure of the main stems 45 and resilient spring arms35, 37 in combination with the frictional withdrawal through (under)magnets 130-133 resists withdrawal, but the resistance can be easilyovercome. Nevertheless, this resistance of the mesh strip 3 results inan incremental release, and the surgeon experiences a commensuratetactile feel as the mesh 3, 4 is released. The surgeon can moreeffectively index the exact length of mesh 3 that is extracted from meshstabilizer 30 purely by feel. The free end of each mesh strip 3 or 4 maybe extracted manually during the procedure to exactly the length neededfor proper placement and fixation to the sacrospinous ligaments. Thiseliminates the propensity of loose portions of the mesh 3 to drape overand obscure the site of interest during fixation, and reduces the riskof the mesh 3 bunching or being sutured too tight.

The method of use is nearly the same for a single Y-shaped mesh 4 (as inFIG. 2) except that the main stem of the Y is folded accordion-style andseated into the trough of the bent and U-shaped mesh stabilizer 30between the two diverging main stems 45 at junction 37. There is amplespace within the trough of the (now-bent and UN-shaped) mesh stabilizer30 to seat the accordion-folded end of Y-shaped mesh 4. The foldingcontinues up the diverging strips of the Y-shaped mesh 4 exactly asdescribed above and these two resulting stacks of folded mesh 4 areloaded onto the mesh stabilizer 30 as described. After the divergingstrips of the Y-shaped mesh 4 have been secured to the vaginal tissue,the mesh stabilizer 30 can be removed leaving the main stem free forfixation to the sacrospinous ligaments.

FIG. 5 illustrates how the magnetic members 130, 131 are embedded inmolded plastic shell 128 which is then attached to the main stem 45. Thesame configuration is used for magnetic members 132, 133 and shell 129.It is essential to minimize the risk of breakage of any components ofthe present invention, because if said components fall off they arelikely to be left behind in the body cavity and cause post-surgicalcomplications. If magnetic members 130, 131 were riveted or welded tomain stems 45 there may be some risk of dislodgement, but retainingshells 128, 129 reduce any such risk. The retaining shells 128 arepreferably thin elongate oval-shaped members with rounded ends andedges. The magnets 130, 131 may be molded inside plastic retainingshells 128, 129. Each retaining shell 128, 129 may be molded onto thedistal end of main stem 45, or may be molded with one or more lengthwisechannels 51 for insertion of main stems 45. In both cases main stem 45may be formed with a plurality of flanking one-way teeth 49 that preventextraction of main stem 45 from within the retaining shell 128, 129. Inaddition to securing magnets 130, 131, the retaining shells 12, 129serve another purpose in that they diffuse the force of magneticattraction across the entire face of retaining shells 128, 129. Thisreduces the point force of each magnet 130, 131 and makes it easier toslidably dispense mesh 3, 4 underneath.

Given the above-described loading of a payload of mesh 3, 4 onto themesh stabilizer 30, the stabilizer 30 itself is then loaded into asterile packaging cartridge where it remains in a compact/compressedconfiguration for introduction by a standard grasper, needle driver,etc., through a laparoscopic port (such as a trocar) into the abdomen.There are several functional considerations which result in a variety ofloading configurations. For example, the packaging cartridge must remainsterile, the mesh 3, 4 must remain in its uniform packed-payloadconfiguration through the loading and deployment processes, and thestabilizer 30 and mesh 3, 4 must unfurl properly once ejected from thepackaging cartridge. For example, FIG. 6 illustrates the packagingcartridge 137 which facilitates the placement of the mesh stabilizer 30into a surgical port (such as a trocar) in preparation for introducingthe mesh stabilizer 30 into a body cavity along with its payload of mesh3, 4. The rudimentary way to get the stabilizer 30 and mesh 3, 4 insidethe packaging cartridge 137 is to fold the spring arms 40 of meshstabilizer 30 together (collapsed) with the preloaded mesh strips 3, 4by squeezing the mesh stabilizer 30 with preloaded mesh 3, 4 laterallywhile simultaneously pulling or pushing the mesh stabilizer 30 and mesh3, 4 into the packaging cartridge 137. In this manner, the meshstabilizer 30 is fully and slidably preloaded into the packagingcartridge 137, cartridge 137 being capped with a collar 134, and is thensterilized and packaged for later use. Collar 134 is an elastomericmember that functions as a gas valve so it can work in conjunction withthe trocar or similar surgical port. The collar 134 is essentially a capwith a central perforation that remains sealed around the protrudingball pin 47 on the mesh stabilizer 30 to maintain insufflation pressurewhen the tubular cartridge 137 is advanced into the laparoscopic trocar60, yet still allowing passage of a laparoscopic grasper or needledriver through the collar 134 to advance the mesh stabilizer 30 into theabdomen. The collar 34 maintains insufflation pressure by sealing aroundthe laparoscopic instrument, similar to other diaphragm valves astypically used in laparoscopic based procedures for allowing laproscopicaccess yet preventing the release of insufflation gases. The packagingcartridge 137 is a tubular member, preferably transparent, with rubbercollar 134 mounted at one end. As seen in FIG. 7, the mesh stabilizer 30loaded with mesh 3, 4 is pulled inside the packaging cartridge 137. Thecartridge 137 is adapted for insertion through a standard trocar or port60 to provide a passage into the body cavity. In this compact state, themain stems 45 and spring arms 35, 37 are constrained in a closed statefor introduction through the surgical port (60) and into the abdomen.The preloaded packaging cartridge 137 may be placed in the surgical port60 (FIG. 8). A surgeon can then easily introduce the mesh stabilizer 30into the body cavity using standard laparoscopic tools. Since the meshstabilizer 30 is compressed, the grasping tab 47 (FIG. 6.) remains fullyaccessible at the very center and is accessible by conventionallaparoscopic tools to push the mesh stabilizer 30 through the port 60into the abdomen (the cartridge 137 remains in the port 60). The naturalexpansion of the mesh stabilizer 30 deploys and unfurls the onboard meshfrom a compressed configuration (unwrinkes the mesh).

In practice, the mesh stabilizer 30 may be packaged as a pre-loaded (orsemi-preloaded) sub-assembly inside cartridge 137 as shown in FIG. 6,but is more preferably loaded in the cartridge by the surgeon just priorto the surgical procedure.

The inventors have found two recurring deployment issues and havedeveloped solutions. The mesh 3, 4 must remain in its uniformpacked-payload configuration through the loading and deploymentprocesses, and the stabilizer 30 and mesh 3, 4 must unfurl properly onceejected from the packaging cartridge. Specifically, the inventors havefound that if the mesh 3, 4 is loaded onto the mesh stabilizer 30,packed into the cartridge 137, and left unused for a prolonged period,the mesh 3, 4 has a tendency to retain its packed shape and may notadequately unfurl. Consequently, it is preferable to load the mesh 3, 4onto the mesh stabilizer 30 and pack the assembly into the cartridge 137just prior to the procedure. This reduces the shape memorycharacteristic of the mesh 3, 4 and assures adequate deployment, butrequires packing by a surgeon or technician rather than themanufacturer. The inventors have also found that abruptly compressingthe loaded mesh stabilizer 30 into the cartridge 137 can in someinstances disrupt the mesh 3, 4, and the resulting disarray can makelater dispensing of the mesh 3, 4 more difficult. FIG. 8 illustrates apacking funnel 70 which may be provided to simplify just-in-time packingof the mesh 3, 4 onto mesh stabilizer 30 and then into the cartridge137. The packing funnel 70 is a hollow tube having a gradually taperedwall section 71 leading to an annular collar 72. The collar 72 isadapted for slidable insertion over the mouth of the cartridge 137. Withpacking funnel 70 mounted to cartridge 137, the packed mesh 3, 4 on meshstabilizer 30 may be drawn into the cartridge 137 through the packingfunnel 70, thereby gradually and automatically folding the packed meshstabilizer 30 into its compact folded configuration within the cartridge137. This is accomplished by inserting a conventional laparoscopic tool(e.g.—grasper or introducer) through the valved collar 134 and cartridge137, grasping the protruding grasping tab 47, and pulling the meshstabilizer 30 into the cartridge 137 through the packing funnel 70. Thegradually tapered walls 71 avoid snagging and disruption of the mesh 3,4. The packing funnel 70 is then removed with the mesh stabilizer 30fully and slidably preloaded into the packaging cartridge 137, andcartridge 137 is ready for just-in-time use as described above. Packingfunnel 70 greatly facilitates just-in-time packing and use of the meshstabilizer 30 by attending physicians or nurses.

FIGS. 9-10 illustrate two additional (optional) features designed tofacilitate loading and to maintain the accordion-folded configuration ofmesh 3, 4 throughout loading and deployment.

FIG. 9 shows the use of a loading tether 80, which is a length of cordthreaded through the valved collar 134 and cartridge 137, funnel 70,around the accordion-folded mesh payload 3, 4 on the mesh stabilizer 30,and back out as shown. Loading tether 80 is preferably wound around bothfolded mesh strips 3, 4 such that it serves as a lasso, binding thelayers of mesh together. This way, rather than inserting a grasper orintroducer through the valved collar 134, the surgeon need only graspthe loose ends of loading tether 80 and pull, drawing the meshstabilizer 30 into the cartridge 137 through the packing funnel 70.Again, the gradually tapered walls 71 of funnel 70 avoid snagging anddisruption of the mesh 3, 4 and maintain its folded configuration.Moreover, as the tether 80 is pulled it constricts both folded meshstrips 3, 4 and keeps the layers of mesh 3, 4 bound on their foldedconfiguration throughout compaction in funnel 70 and loading of the meshstabilizer 30 into cartridge 137. This further avoids disruption of themesh 3, 4 and maintains a proper folded configuration. Once the meshstabilizer 30 is packed the tether 80 can simply be removed by pullingone loose end.

FIG. 10 shows the use of a protective skirt 85, which is a panel of verythin but durable flexible low-friction sheet material such as Mylar™ orother plastic sheet, woven fabric, or the like. Protective skirt 85 ismounted centrally on the protruding tab 47 and forms a protective coverover the folded mesh 3, 4 maintaining a low friction surface between themesh 3, 4 and interior of the funnel 70 and cartridge 137, protectingthe folded mesh, and reducing the tendency of the mesh 3, 4 to catch orsnag during loading. Any of the above-described loading procedures maybe used inasmuch as the protective skirt 85 does not interfere, and oncethe cartridge 137 is loaded the protective skirt 85 may be removed orleft in place through the procedure. One skilled in the art shouldunderstand that the above-described loading features including funnel70, tether 80, and skirt 85 may be used alone or in combination, and inall such cases avoids disruption of the mesh 3, 4 and maintains a properaccordion-folded configuration during loading.

Once loaded, mesh stabilizer 30 may be introduced into the abdomen asdescribed above where it is pushed out of the cartridge 137, expandingto the configuration shown in FIG. 3, and then magnetically docked tothe vaginal probe 10 which precisely positions/anchors the meshstabilizer 30 and its payload to the tissue of the vaginal apex insidethe abdominal body cavity. The surgical tool used for introducing themesh stabilizer is then removed. The docking engagement holds the meshstabilizer 30 with mesh straps 3, 4 in place in the desired site withthe muscular walls of the vagina lying between the vaginal probe and themesh stabilizer. The surgeon is free to dispense mesh 3, 4 from thestabilizer 30 and/or adjust the position of the mesh relative to thevaginal apex and mesh stabilizer 30 while still maintainingstabilization of the mesh on the vaginal apex. This greatly facilitatesfixation of the mesh to the anterior and posterior vaginal walls. Afterpermanent fixation, driver surgical tool may be reinserted into theabdomen through the surgical port and used to retrieve the meshstabilizer 30. The stability of the system results in a less complex andpotentially less time consuming procedure, and may facilitate acceptanceby many surgeons toward a minimally invasive approach(e.g.—single-incision laparoscopic or robotic approach) tosacrocolpopexy.

The present invention is suited for use with any surgical table, andboth components 10, may be manually, mechanically or roboticallymanipulated. The vaginal probe 10 may be distally mounted on aflexible/locking stabilizing arm of a surgical table that therebysecurely holds the probe 10 during the sacral colpopexy procedure (whichindeed requires a stable probe during fixation of mesh to the vagina),or a manually supported probe.

When the mesh stabilizer 30 is deployed into the lower abdominal cavity,the opposing main stems 45 and spring arms 35, 37 and opposing foldablemesh 3, 4 unfurl to its open position (shown in FIG. 3). The probe 10 isinserted into a fixed opposing position within the vagina, and the meshstabilizer 30 embraces and docks with the probe 10, collapsing aroundthe top and bottom walls of the vaginal muscularis. When the meshstabilizer 30 is fully docked with the probe 10 it sandwiches both themesh and vaginal muscularis there between so that one strap of mesh 3, 4sits opposed to the vaginal walls. This securely positions the mesh onthe vaginal walls to which it will be secured, and adds some frictionalresistance to withdrawal of the mesh through the closed-loop portion ofthe mesh stabilizer 30 stabilizing framework, thereby allowing thesurgeon to adjust the position of the mesh relative to the vaginal apexand mesh stabilizer while still maintaining stabilization of the mesh onthe vaginal muscularis.

Virtually any vaginal probe may be modified for use with the presentinvention (including vaginal probes without magnets), but to improvestabilization of the mesh stabilizer 30 on the vaginal apex the magneticattachment is recommended). FIGS. 11 and 12 are top and bottom sideperspective views, respectively, of an exemplary vaginal probe 10. Probe10 generally comprises a body 102 leading to a shaft 104 for insertionin the vagina, and a probe head 106 distal on the shaft 104. The probehead 106 is slightly flattened, with a generally oval horizontal andvertical cross-section flaring outward from the shaft 104, with roundedcorners and edges so that it is more anatomically shaped to betterconform the natural shape of the vagina than conventional vaginalprobes. The probe head 106 may be tapered rearwardly of the tip toprevent inadvertent pop-off of the mesh stabilizer 30. Exemplarydimensions are 7 cm×5 cm×2.5 cm×4 cm, resulting in a 5 cm×2.5 cm probeend. The thicker tip can help prevent the spring arms 35, 37 of thestabilizer 30 from coming off (especially if the embodiment reliesstrictly on clamping). The shape of the probe head 106 may take on avariety of configurations as a matter of surgical discretion, and anexemplary set of probe head configurations specially suited for sacralcolpopey are shown and described in co-pending U.S. Provisional PatentApplication 61/636,171 filed 21 Apr. 2012.

In summary, after loading the mesh stabilizer 30 as described above,deployment generally includes six discrete steps: 1) opening; 2)coupling; 3) detachment; 4) extraction; 5) fixation, and 6) removal.

At 1) opening, the mesh stabilizer 30 is pushed into the abdomen withdriver conventional laparoscopic tool, extending into abdomenal region.Once in the abdomen, the stabilizer 30 is exposed (freed from cartridge137), and main stems 45/spring arms 35, 37 of the mesh stabilizer 30open to a deployed U-or-V-shaped position as shown in FIG. 3.

At step 2) coupling, the open main stems 45 and spring arms 35, 37 areadvanced over the vaginal apex and probe 10 head to begin the magneticdocking between the magnetic members of the mesh stabilizer 30 and thevaginal probe 10 head. The probe head 6 remains stationery.

At 3) detachment, the conventional laparoscopic tool that was used tointroduce the mesh stabilizer 30 is removed leaving the stabilizer 30attached to the vaginal apex and probe 10.

At 4) extraction, the mesh 3, 4 is manually extracted to the properlength and position for fixation in accordance with the method forextraction described herein.

At 5) fixation, the surgeon has an unobstructed view of the vaginalmuscularis because the excess mesh straps are being contrained by themesh stabilizer 30 and not hanging down and obscuring the surgeonsvision, which facilitates the fixation of the mesh straps to the vaginalmuscularis.

Upon completion of fixation, driver conventional laparoscopic tool canbe reinserted and reattached to the stabilizer 30.

At removal 6) the mesh stabiler is removed from the abdomen back throughthe surgical port 60.

One skilled in the art should readily understand that there may be othermechanical mechanisms to achieve the requisite docking between the probehead 106 and mesh stabilizer 30, and the illustrated mechanisms areexemplary. In addition to the basic functionality described above, theprobe 10 may be modified as desired to improve suitability to the task.For example, there may be one probe design for use with a flush vaginalvault, and one for use with a retained cervix. Alternatively, thevaginal probe 10 may be provided with a plurality of detachable tips foraccomodating different vaginal configurations including the retainedcervix. The vaginal vault probe may be equipped with a graspingmechanism at its tip to further stabilize the vagina and furtherminimize the risk of inadvertent pop-off of the mesh stabilizer 30 fromthe vaginal apex and the vaginal probe. The locking mechanism may bepaired built-in grasping forceps, paired conical tips that preventslippage without grasping, or paired suction channels to preventslippage by creating a vacuum between the probe and the vaginalmuscularis. A retained cervix vaginal probe must accommodate the cervixat its anterior tip. This may entail a shorter probe component thatwould sit within the endocervix to stabilize the cervix. Again, theprobe 10 may contain some form of grasping component as described aboveto further stabilize the cervix and pull it flush against the probe.

Having now fully set forth the preferred embodiment and certainmodifications of the concept underlying the present invention, variousother embodiments as well as certain variations and modifications of theembodiments herein shown and described will obviously occur to thoseskilled in the art upon becoming familiar with said underlying concept.It is to be understood, therefore, that the invention may be practicedotherwise than as specifically set forth in the appended claims.

What is claimed is:
 1. A method for loading a payload of surgical meshonto a mesh stabilizer device for laparoscopic introduction into a humanbody cavity, comprising the steps of: obtaining an elongate section ofsurgical mesh; loading said section of mesh onto a pair of dispensingarms in said mesh stabilizer device such that said dispensing armspenetrate successive layers of said mesh through a weave of said mesh.2. A surgical mesh stabilizer, comprising a wireframe elastic bodyformed with opposing mesh stabilizing frameworks joined together at ajuncture, each of said mesh stabilizing frameworks including a pair ofoutwardly-protruding spring arms for tensioning and anchoring surgicalmesh there beneath, and a pair of resilient dispensing arms divergingoutward from said spring arm for insertion through an elongate sectionof surgical mesh folded accordion-style lengthwise such that saiddispensing arms penetrate successive layers of said folded mesh throughits pores.